ABSTRACT
OBJECTIVES: We examined the effects of INM 176 (K-1107) compared with placebo on the cognitive functions of 92 old aged subjects with cognitive impairment. METHODS: This was a prospective, 12 week, double-blind, placebo-controlled clinical trial. The elderly who achieved a score of less than 25 points on the K-MMSE or showed a high risk of Alzheimer's disease from the 7-Minute Neurocognitive Screening Battery were considered to have objective impairment and were selected as subjects for this study. The subjects were randomized to placebo or INM 176 group. The outcome measures were from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog), the Instrumental Activities of Daily Living (IADL) and the Korean Geriatric Depression Scale (KGDS) and two kinds of computerized priming tests. After setting the total error score in the Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog) as the repeated measurement factor, an analysis of variance of the combined factor design was done between the placebo and INM 176 group. RESULTS: The interaction effect of time (pre- and post- trial) and group (placebo and INM 176 group) was significant in the analysis of the ADAS-cog's total error score. The INM 176 group's total error score in the ADAS-cog decreased significantly (p<0.01), whereas the placebo group showed a slight increase. The mean changes in IADL and GDS from baseline scores favored in the INM 176 group than in the placebo group. Outcome changes of ADAS-cog, IADL, KGDS scores during the 12 week clinical trail of INM 176 and placebo demonstrated favorable responses in the INM176 administered group. CONCLUSIONS: This is a preliminary clinical trial result of INM176 as a memory pill. Based on these results, INM176 may be a candidate molecule for the improvement of cognitive functions, including memory. Further clinical trial should demonstrate its efficacy.